Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06378099

Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments

Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a specific minor ailment. It involves advice on nonprescription drugs, non-pharmacological measures, or referral to another health care practitioner. In Colombia, evaluating and implementing this service could optimize nonprescription drugs use and improve minor ailment management in primary health care settings.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Community Pharmacy Services Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Farmacias Pasteur S.A.

Medellín, Antioquia, 050001, Colombia

Location status: Recruiting

Location contact

Olga Henao

CONTACT

[email protected]

+573103895657

About this study

A 10-month parallel-group clinical trial will be conducted in drugstores and pharmacies (ambulatory retail establishments) in Medellín and the Metropolitan Area. Patients requesting nonprescription drugs for one of five predefined minor ailments (influenza-like syndrome, common cold, headache, dysmenorrhea, or sore throat) will be eligible. Establishments, randomized by cluster sampling, will be allocated to either the intervention (management using CBPs) or control (standard management + education on responsible self-medication) group. Pharmacy staff will receive training in appropriate CBP use. Eligible patients will be consecutively enrolled and followed-up by the research team on days 3, 5, 7, and 10 after the consultation in both groups. Analyses will be performed using Python, including descriptive statistics, bivariate comparisons (p < 0.05), and multivariate Cox regression for significant variables. An intention-to-treat approach will address missing data and dropouts.

The aim of this study is to evaluate the effect of Consensus-based Protocols (CBPs) on the management and duration of some MA, and on the referral rate to General medical Practitioner (GPs) in drugstores and pharmacies. Secondary outcomes include: 1) To clinically and socio-demographically characterize the population that visits a drugstore or pharmacy requesting a nonprescription drug to manage a MA, and 2) To assess the management, duration, rate and causes of GP referrals in drugstores and pharmacies with the use of CBPs among patients requesting nonprescription drugs for the management of a potential MA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Drugstores and drugstores/pharmacies:

  • Establishments located in Medellin and Metropolitan area
  • Establishments that have a Pharmacy Technician serving as the technical director.
  • Establishments with electronic point-of-sale system for data collection.
  • Commitment to participate for the full 10-month study period.

Participants (patients):

  • Explicit consent to participate in the study.
  • Are the direct consumers requesting the nonprescription drug (i.e., not requesting them on behalf of someone else).
  • Present one of the five predefined potential MA that will be included in the study: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps.
  • Have access to mobile phone for follow-upThe person requesting the OTC medication must be the end consumer of it.

Exclusion criteria

  • Subjects who refuse to sign the informed consent
  • Subjects with an evident incapacity to complete the data questionnaire
  • Pregnant or breastfeeding women
  • Patients whose MA result from an ADR
  • Patients with symptoms lasting more than seven days

Treatment and study plan

Patient guided and followed by the pharmacist

Other

The Study Coordinating Group will train the pharmacy Staff regarding these protocols.

This training will cover both pharmacological and non-pharmacological aspects of MA management. The pharmacological component will emphasize the appropriate selection and safe use of nonprescription drugs, with a focus on identifying potential drug interactions, contraindications, and moderate and serious ADRs. Pharmacy staff will also be equipped with tools to apply proper criteria for referral to a GP when necessary.

The staff will be divided into three groups, and every group will have a minimum of two sessions, each one of 4 hours. Additionally, there will be a practical component where simulations of real situations will be conducted.

Throughout the 12-month follow-up and intervention period, one of the researchers will be available to receive phone calls to address doubts and concerns about the Consensus-based Protocols.

Other names: Use of consensus-based protocols

Primary outcomes

  1. MA resolution

    Time frame: 12 months

    MA resolution will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.

    MA resolution will be recorded as a binary outcome (yes/no). This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.

  2. MA duration

    Time frame: 12 months

    The duration of the MA will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.

    MA duration will be measured in days from the intervention at the drugstore or pharmacy to complete symptom resolution or if a referral to a GP is needed. This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.

  3. Referral rate to GP

    Time frame: 12 months

    Referral rate to GP, both due to symptoms worsening or occurrence of moderate or serious ADRs, will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.

    Based on patients' responses to follow-up questionnaires, referral to a GP will be recorded as a binary outcome (yes/no), indicating whether a referral occurred due to symptom worsening or suspected moderate or serious ADRs. This measure is relevant for evaluating patient safety and the effectiveness of the intervention with CBPs.

Secondary outcomes

  1. Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA

    Time frame: 3 months

    Sociodemographic and clinical data (e.g., age, sex, education level, prior use of nonprescription drugs) will be collected only at baseline (T0), before the intervention. This data will help contextualize the findings and identify population-specific factors influencing outcomes.

  2. Identification and classification of the MA

    Time frame: 12 months

    In both the intervention and control groups, the presence and type of MA will be recorded at baseline (T0). In the control group (standard management + education on responsible self-medication), the patient will self-identify and classify the MA, whereas in the intervention group (management using CBPs), this will be done by the pharmacy staff following protocolized classification criteria. The outcome is relevant to verify the presence of a MA within drugstores and pharmacies.

  3. Need for a nonprescription drug to treat the MA

    Time frame: 12 months

    This binary variable (yes/no) will be assessed in both groups at baseline (T0) and will indicate whether the patient obtained a nonprescription drug for MA management. In the control group (standard management + education on responsible self-medication), medication selection will be driven by the patient's decision. In the intervention group (management using CBPs), this decision will be guided by the pharmacy staff in accordance with the CBPs. Clinically, this informs the appropriateness and potential rationalization of nonprescription drug use under protocol-based pharmaceutical guidance.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Salazar

CONTACT

[email protected]

+573017971909

Milena Ortiz

CONTACT

[email protected]

+573175007349

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • Farmacias Pasteur

Registry information

Official study title

Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments in Drugstores and Pharmacies in Medellin and the Metropolitan Area, Colombia: A Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.